NCT00026429

Brief Summary

RATIONALE: Biological therapies such as denileukin diftitox may be able to deliver cancer-killing substances directly to non-Hodgkin's lymphoma cells. PURPOSE: Phase II trial to study the effectiveness of denileukin diftitox in treating patients who have non-Hodgkin's lymphoma.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2001

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

February 27, 2004

Completed
Last Updated

December 18, 2013

Status Verified

February 1, 2002

First QC Date

November 9, 2001

Last Update Submit

December 17, 2013

Conditions

LeukemiaLymphoma

Keywords

stage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarefractory chronic lymphocytic leukemiaB-cell chronic lymphocytic leukemiastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I adult diffuse small cleaved cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomastage I mantle cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II mantle cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue

Interventions

denileukin diftitoxBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed low-grade B-cell non-Hodgkin's lymphoma (NHL) Working Formulation classification: Small lymphocytic lymphoma Follicular lymphoma (small cleaved or mixed small and large cell) REAL classification: B-cell chronic lymphocytic leukemia/small lymphocytic Lymphoplasmacytoid Marginal zone/MALT Follicular small or mixed small and large cell OR Histologically confirmed intermediate-grade B-cell NHL Working Formulation classification: Follicular large cell Diffuse small cleaved cell Diffuse mixed small and large cell Diffuse large cell REAL classification: Mantle cell Diffuse small cell Marginal zone/MALT Large B-cell Lymphoplasmacytoid Stage I, II, III, or IV disease No cutaneous T-cell lymphoma or other T-cell NHL Bidimensionally measurable disease Unidimensionally measurable disease allowed for mediastinal lymphoma only if outside previously irradiated field or there is evidence of progression Received prior monoclonal antibody therapy OR ineligible for monoclonal antibody therapy A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 1.5 times ULN Albumin at least 3.0 g/dL No chronic hepatitis Renal: Creatinine less than 1.8 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No poorly controlled hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No serious concurrent illness or active infection requiring parenteral antibiotics that would preclude study No known hypersensitivity to study drug or its components, including diphtheria toxin, interleukin-2, or excipients No other malignancy within the past 5 years except resected basal or squamous cell skin cancer or carcinoma in situ of the cervix (prostate cancer in situ or breast cancer in situ within the past 5 years is allowed if patients are in complete remission with no active disease, have stable tumor markers for at least 3 months, and have a life expectancy of at least 2 years) PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior bone marrow transplantation allowed No prior denileukin diftitox or DAB486 IL-2 No concurrent immunotherapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent hormonal anticancer therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to sole site of disease unless evidence of progression No concurrent radiotherapy Surgery: Not specified Other: At least 1 month since prior investigational agent No other concurrent experimental medications, including approved drugs tested in an investigational setting

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

ION/Pharmatech Network

Pomona, California, 91767, United States

Location

Cancer and Blood Institute of the Desert

Rancho Mirage, California, 92270, United States

Location

Missouri Cancer Care, P.C.

Saint Charles, Missouri, 63301, United States

Location

Nassau Hematology/Oncology PC

Lake Success, New York, 11042, United States

Location

Coastal Cancer Center

Myrtle Beach, South Carolina, 29572, United States

Location

Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma, B-Cell, Marginal Zone

Interventions

denileukin diftitox

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-Cell

Study Officials

  • Debby Henkens

    Pharmatech Oncology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 9, 2001

First Posted

February 27, 2004

Study Start

January 1, 2001

Last Updated

December 18, 2013

Record last verified: 2002-02

Locations

US(6)